Recall of Contaminated Castile Soap Towelettes in Medical Kits
FDA is recalling specific lots of Castile soap towelettes used in medical kits due to bacterial contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (bacteria) in a medical device context without reported illnesses, fitting the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of Aplicare Castile Soap towelettes. These towelettes are included in Foley Trays and Midstream specimen kits manufactured by Covidien LLC. The products are used to clean the genital area for male and female patients.
The recall is being issued because the towelettes are contaminated with bacteria. The affected product is the Covidien Dover MIDSTREAM KIT RING CASTILE, Item Code 4090SA. The specific lot codes involved are 513287864X, 514688164X, 518187764X, 520288464X, and 523087364X.
A total of 207,000 units were distributed nationwide in the United States and to Canada. Consumers and healthcare providers should stop using these specific lots of towelettes and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 207,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Codes: 513287864X 514688164X 518187764X 520288464X 523087364X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 34 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08